ENCYSIVE WINS AUSTRALIAN APPROVAL FOR THELIN

Encysive Pharmaceuticals announced that the Australian Therapeutic Goods Administration (TGA) has approved its Thelin 100-mg tablets as a once-daily treatment for pulmonary arterial hypertension.

Thelin (sitaxentan sodium) is the first selective endothelin A receptor antagonist and first once-daily oral treatment available for pulmonary arterial hypertension, the company said. The drug has been shown to be effective in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease. A TGA review panel had recommended approval of the drug in December 2006.

"Approval in Australia marks another proud achievement for Encysive's global Thelin development program," Bruce Given, president and CEO of Encysive, said. "We will continue our focus of rolling out Thelin abroad while we await the FDA's decision in the United States."

After Encysive submitted an application for U.S. approval, the FDA responded by asking for more clinical trials. The drug was approved in Europe in August 2006.

The company has conducted two randomized, placebo-controlled, Phase III studies of Thelin. The drug was shown to significantly improve exercise capacity, as measured by improvement in six-minute walk distance.